Non-invasive determination of the condition of biological tissues is useful in particular where the patient is unable to co-operate or the tissue is inaccessible for easy monitoring.
Techniques presently used in determining the characteristics of biological tissues include x-rays, magnetic resonance imaging (MRI) and radio-isotopic imaging. These are generally expensive and involve some degree of risk which is usually associated with the use of X-rays, radioactive materials or gamma-ray emission. Furthermore, these techniques are generally complicated and require equipment which is bulky and expensive to install and, in most cases, cannot be taken to the bedside to assess biological tissues in patients whose illness prevents them being moved. The present invention provides methods and apparatus which alleviate these difficulties, providing non-invasive, cost-effective and ambulatory means for assessing and monitoring the condition of biological tissues in humans and animals alike.
Sound waves, particularly in the ultra-sound range have been used to monitor and observe the condition of patients or of selected tissues, such as the placenta or fetus. However, the process requires sophisticated and sometimes expensive technology and cannot be used in tissues in which there is a substantial quantity of gas, such as the lung.
Every year in Australia about 5000 newborn infants require a period of intensive care (ANZNN Annual Report, 1996-1997). Respiratory failure is the most common problem requiring support and is usually treated with a period of mechanical ventilation. Over the last decade the mortality of infants suffering respiratory failure has shown an impressive decline, attributable at least in part to improved techniques used in mechanical ventilation, and the introduction of surfactant replacement therapy (Jobe, 1993). The vast majority of infants now survive initial acute respiratory illness, but lung injury associated with mechanical ventilation causes many infants to develop ‘chronic lung disease’. Chronic lung disease is characterised by persisting inflammatory and fibrotic changes, and causes over 90% of surviving infants born at less than 28 weeks gestation, and 30% of those of 28-31 weeks gestation, to be dependent on supplementary oxygen at 28 days of age. Of these, over half still require supplementary oxygen when they have reached a post-menstrual age of 36 weeks gestation (ANZNN Annual report, 1996-1997). Assistance with continuous positive airway pressure (CPAP) or artificial ventilation is also commonly required.
Historically, barotrauma and oxygen toxicity have been considered to be the primary culprits in the aetiology of chronic lung disease (Northway et al, 1967; Taghizadeh & Reynolds, 1976). However, trials of new strategies in mechanical ventilation which were expected to reduce barotrauma and/or exposure to oxygen have often had disappointingly little impact on the incidence of chronic lung disease (HIFI Study Group, 1989; Bernstein et al, 1996; Baumer, 2000). Comparison of strategies of conventional mechanical ventilation in animals (Dreyfuss et al, 1985) have indicated that high lung volumes may be more damaging than high intrapulmonary pressures, and has led to the concept of ‘volutrauma’ due to over-inflation of the lung. At the same time, experience with high frequency oscillatory ventilation (HFOV) has indicated that avoidance of under-inflation may be equally important. HFOV offers the potential to reduce lung injury by employing exceptionally small tidal volumes which are delivered at a very high frequency. However, this technique fails to confer benefit if the average lung volume is low (HIFI Study Group, 1989), yet it appears to be successful if a normal volume is maintained (McCulloch et al, 1988; Gerstmann et al, 1996). This highlights the importance of keeping the atelectasis-prone lung ‘open’ (Froese, 1989). Evidence of this kind has led to the concept that a ‘safe window’ of lung volume exists within which the likelihood of lung injury can be minimised. The key to preventing lung injury may lie in maintaining lung volume within that safe window thereby avoiding either repetitive over-inflation or sustained atelectasis. (See FIG. 1).
Attempts to maintain an optimal lung volume in the clinical setting are frustrated by a lack of suitable methods by which the degree of lung inflation can be monitored. In current practice, evaluation of oxygen requirements and radiological examination of the lungs are the principal techniques employed. However, oxygen requirements may be influenced by factors other than lung volume (for example intra- or extracardiac right to left shunting), and the hazards of radiation exposure prevent radiological examination being performed with the frequency required.
Monitoring of infants during mechanical ventilation has been significantly improved over the last decade by the incorporation of a pneumotachograph or hot-wire anemometer into the design of many neonatal ventilators. Although this provides a valuable tool for monitoring tidal volume and compliance, it gives only the most indirect indication (from the shape of the pressure-volume curve) of whether that tidal volume is being delivered in a setting of under-inflation, optimal inflation, or over-inflation. Furthermore, while absolute lung gas volume can be measured using ‘gold-standard’ techniques of Nitrogen (N2) washout or Helium (He) dilution, these are impractical for routine clinical use.
Even when lung volume is maintained in the “safe window”, changes in the lung condition may manifest due to the generally damaged or underdeveloped condition of the lung. Fluid and blood may accumulate in the lung, posing additional threats to the patient. Evaluation with a stethoscope of audible sounds which originate from within the lung (breath sounds) or are introduced into the lung (by percussion, or as vocal sounds) forms an essential part of any routine medical examination. However, in the sick newborn, the infant's small size, inability to co-operate and the presence of background noise greatly limits the value of such techniques.
Whilst determining and monitoring lung condition in newborn babies is difficult, determining lung condition in adults can be equally challenging, particularly if a patient is unconscious or unable to cooperate. This places a further limitation on the presently available techniques for monitoring lung condition. Therefore, a clear need exists for a simple, non-invasive and convenient method by which the condition of the lung can be closely monitored in the clinical setting.
Similarly, there is a need for simple, non-invasive and convenient methods and apparatus for determining the condition of other biological tissues which may be prone to changes in their characteristics, through pathology or otherwise.
For example, it would be very useful to be able to monitor the state of the airways. This can be especially useful for example in the determination of airway patency and in the determination of sleep-disordered breathing.
Sleep-disordered breathing is an increasingly recognised clinical problem, with severe obstructive sleep apnea affecting an estimated 5% of adults and 2% of infants.
In sleep-disordered breathing a reduction in airflow to the lungs may result in reduced blood oxygen levels (hypoxemia) and arousal from sleep. This airflow reduction and arousal can occur many times a night, and can have a number of adverse effects, including excessive daytime sleepiness and an increased incidence of cardiovascular disease and stroke.
In obstructive sleep apnea, a patient's upper airway may be prone to collapse during sleep, thereby causing an obstruction and hypoxemia. This in turn causes the patient to enter a waking state for a short time period. The airway is then re-opened, airflow is re-established, and the patient immediately returns to sleep. This sequence of events may repeat many times throughout the night.
Apnea is generally characterised by a cessation of airflow for 10 or more seconds, and may be classified as obstructive apnea (caused by a blockage of the airway), central apnea (e.g. lack of breathing effort caused by an unstable respiratory control system or as a result of a neurological condition), or mixed apnea (a combination of both).
Sleep-disordered breathing may also relate to hypopnea, which is generally characterised as a reduction of airflow, and for example may be due to an airway that is partially obstructed or may be of central origin, resulting from a reduced output from the respiratory centre in the brain stem. It may also relate to other conditions, such as Upper Airway Resistance Syndrome (UARS), in which there is a reduction in airflow involving arousal, but there may be no significant lowering of blood oxygen levels.
At present, the diagnosis of sleep-disordered breathing is difficult and is generally carried out by a polysomnography test, in which a number of physiological variables of a patient are monitored overnight in a sleep laboratory. This must be followed by a detailed analysis of the resulting data by an experienced sleep scientist, and requires a rigorous comparison of multiple traces. It is expensive, time-consuming and subject to inaccuracies.
Other methods of determining airway obstruction also exist. For example, an oesophageal balloon catheter may be used to measure oesophageal pressure, and, in association with inspiratory airflow, this may be used to calculate upper airway resistance. Such methods are however too invasive for routine clinical use.
The present invention, in its various aspects, aims to provide new and useful apparatus, systems and methods for monitoring the state of an airway and for monitoring patency.